MAUDE Adverse Event Report: UNOMEDICAL A/S UNO COMFORT 80/17 SC1 MINI; MINIMED C, SILHOUTTEA C

Model Number	MMT-384A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	07/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient was hopsitalized due to high bg.Patient received iv insulin drip as a corrective treatment.No further information available.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Supplemental report 01 - (b)(4) - mdr 3003442380-2024-15175.Correction: this mdr is being submitted to correct the submitted expiration date under d4 and manufacturing date under h4.Additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary: the information in this complaint (b)(4) has been evaluated for the malfunction code no malfunction based on complaint information.The batch 6001663 in question was manufactured at the reynosa site.Test results: complaint investigation: the reference samples cannot be tested because there was no specific malfunction to investigate.Device history record (dhr) review: the lot 6001663 was manufactured according to the work instruction (wi) version 14 packaging in the multivac10, on12/jun/2024, with a total of (b)(4) units.Review of the dhr showed that all relevant tests required during the related processes had been fulfilled and met the requirements.No deviation were identified related to the malfunction reported, no maintenance events were recorded.Trending: a query was run in database on 29-jul-2025 against harm code untreated diabetic ketoacidosis which the patient is unable to self-manage requiring intervention by a health care professional (hcp) or requires emergency advanced, malfunction code no malfunction describe and lot 6001663 and one complaint more has been registered in database for the same lot, harm code and malfunction code.Conclusion summary of complaint investigation: as a result of the following: no non-conformance (nc) raised during production, one complaint more has been received on the lot in question and harm code, the test on reference samples were not tested since a no malfunction related to the infusion set was reported, therefore no further actions are required.This complaint will not require further root cause investigation nor capa plan.Therefore, this issue will be monitored through the post market surveillance activities.

• Brand Name: UNO COMFORT 80/17 SC1 MINI
• Common Device Name: MINIMED C, SILHOUTTEA C
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19779851
• Report Number: 3003442380-2024-15175
• Device Sequence Number: 15492310
• Product Code: FPA
• UDI-Device Identifier: 05705244019676
• UDI-Public: 05705244019676
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/11/2026
• Device Model Number: MMT-384A
• Device Lot Number: 6001663
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown